MAUDE Adverse Event Report: MEDIVATORS, INC. ENDOGATOR IRRIGATION TUBING; ENDOSCOPIC IRRIGATION/SUCTION SYSTEM

Catalog Number 100611

Device Problems Bent (1059); Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/26/2016

Event Type  malfunction  

Event Description

The endogator tubing cap cracked during the case, 3 have occurred during the week.Review taken place, the gi department had switched to a more concentrated form of peppermint oil which made the plastic bend, using a more diluted peppermint.This is typical that the peppermint oil is used with gi procedures.

• Brand Name: ENDOGATOR IRRIGATION TUBING
• Type of Device: ENDOSCOPIC IRRIGATION/SUCTION SYSTEM
• Manufacturer (Section D): MEDIVATORS, INC.; 3150 pollok drive; conroe TX 77303
• MDR Report Key: 6050277
• MDR Text Key: 58148591
• Report Number: 6050277
• Device Sequence Number: 1
• Product Code: OCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 100611
• Device Lot Number: 795207
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/13/2016
• Event Location: Other
• Date Report to Manufacturer: 10/13/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1